Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis

Официальное название

Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

Обзор

The central hypothesis of this study is that the addition of dupilumab treatment onto standard-of-care intranasal corticosteroids will improve patient-reported measures of disease activity and sense of smell in a cohort of mostly ethnical and racial minority patients with CRSwNP

Подробное описание

First, it will confirm the effectiveness of dupilumab in the treatment of CRSwNP in ethnic and racial minority patients who have traditionally been underrepresented in existing clinical trials of biologics in CRSwNP Second, this research will establish a biomarker of therapeutic response to dupilumab identifying the biological effect of dupilumab in CRSwNP patients and its association with symptom improvement.

Finally, the investigators will measure the effect of dupilumab on asthma symptoms and lung function in patients with CRSwNP and comorbid asthma.

There will be a screening visit, followed by a baseline visit where the medication will be given. Follow-up visits will be scheduled at 2 weeks and then 16 weeks from baseline. Long-term visits will take place in 36 and 52 weeks.

Вмешательства

• Биопрепарат Dupilumab
  Standard of care treatment with dupilumab

Первичные конечные точки

• Change in Sinonasal outcome test (SNOT-22) score, scale 0-110, higher is worse outcome [Срок оценки: at 2, 16, 36, and 52 weeks of treatment]
• Change in University of Pennsylvania Smell Identification Test (UPSIT) scores, scale 0-40, lower is worse outcome values [Срок оценки: at 2, 16, 36, and 52 weeks of treatment]
• Change in nasal peak flow (NPF) value (L/min) [Срок оценки: at 2, 16, 36, and 52 weeks of treatment]

Вторичные конечные точки (3)

• Change in urinary levels of Leukotriene E4 (uLTE4) levels in ug/L [Срок оценки: at 2, 16, 36, and 52 weeks of treatment]
• Change in peripheral blood eosinophil counts in k/uL [Срок оценки: at 2, 16, 36, and 52 weeks of treatment]
• Change in Immunoglobulin E (IgE) level in IU/mL [Срок оценки: at 2, 16, 36, and 52 weeks of treatment]

Критерии участия

Критерии включения

• Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab.
• Patients aged 18 years and older.
• Patient willing to provide consent to be a participant in the study.
• Patients with insurance that allows Dupilumab coverage or Dupilumab coverage obtained through "Dupixent MyWay Program"

Критерии исключения

• Age under 18
• Suspected or diagnosed allergic fungal rhinosinusitis.
• Suspected or diagnosed cystic fibrosis.
• Dupilumab coverage denied through insurance or "Dupixent MyWay Program"
• Patients who required a steroid taper in the preceding 30 days. However, patients on chronic steroids less or equal to 20 mg of prednisone daily, are eligible.
• Patients who were on a different biologic medication in the preceding 3 months.
• Patients with a diagnosis of EGPA/Churg-Strauss Syndrome
• Pregnant patients
• Patients with inverted papilloma growth

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• Montefiore Medical Center — The Bronx

Публикации

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Идентификаторы

NCT: NCT05246267 · 2021-13161

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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